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KMID : 1142220140090020141
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.141 ~ p.148
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Current Status and Understanding of QbD Implementation in Pharmaceutical Industry
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Jin Su-Eon
Kim Min-Soo
Shin Sang-Mun
Jeong Seong-Hoon
Hwang Sung-Joo
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Abstract
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Quality-by-Design (QbD) is used as a tool to ensure and enhance drug product quality in pharmaceutical industry. It is a science and technology-based approach to improve understandings of pharmaceutical process and critical process parameters and to ultimately enable process control strategies with process analytical technology (PAT) and real time release test (RTRT). QbD implementation in pharmaceutical process can lead to increase production rates and to reduce a burden for end-product testing in traditional Quality-by-Testing (QbT) approach. Finally, patients may have a benefit to take QbD-based qualified drug products with safety and efficacy. QbD, implemented in US/EU and Japan, has been regulated by Q8, Q9, and Q10 of ICH Quality guidelines. For the international harmonization, regulatory authorities and researchers in pharmaceutical industry need to study and undergo QbD system with the understanding of various aspects of QbD elements. In this review, current status of QbD implementation in pharmaceutical industry will be described. A step-by-step guide for QbD implementation from definition to advantages will also be provided.
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KEYWORD
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Quality-by-design (QbD), ICH Quality guidelines, Pharmaceutical process, Quality advancement
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